NCT00378586

Brief Summary

Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of different inflammatory and infectious markers. The investigators hypothesize, therefore, that there is a significant difference in the concentrations of inflammatory and infectious markers in the rectal mucosa between patients with septic shock and healthy controls.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
3.3 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
Last Updated

June 23, 2009

Status Verified

June 1, 2009

First QC Date

September 19, 2006

Last Update Submit

June 22, 2009

Conditions

Septic Shock

Interventions

Rectal biopsyPROCEDURE

Rectal biopsy.

Measurement of inflammatory markers in the rectal mucosaPROCEDURE

IL-6, TNF-alfa.

Measurement of rectal lactic acidPROCEDURE

Equilibrium dialysis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Septic shock patients.

You may qualify if:

  • Septic shock

You may not qualify if:

  • Age \< 18 years
  • No next of kin
  • Pathology of the descending or sigmoid colon or rectum
  • Pregnancy
  • st degree relatives with inflammatory bowel disease
  • Severe coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Intensive Care 4131

Copenhagen, DK-2100, Denmark

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Michael Ibsen, MD

    Dept. of Intensive Care 4131, Rigshospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Ibsen, MD

CONTACT

+ 45 45 35 94 18micibs@dadlnet.dk

Anders Perner, MD, PhD

CONTACT

+ 45 45 35 41 31ap@dadlnet.dk

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 20, 2006

Study Start

January 1, 2010

Last Updated

June 23, 2009

Record last verified: 2009-06

Locations

DK(1)